A randomized trial of the Tubulcus multilayer bandaging system in the treatment of extensive venous ulcers

BACKGROUND: Venous ulcers are a major health problem because of their high prevalence and associated high cost of care. Compression therapy is the most widely used treatment for this condition. The vast majority of published articles on compression therapy present the results in the treatment of venous ulcers usually up to 15 to 20 cm(2). However, there are no published data in English medical literature on the efficacy of compression therapy in the treatment of extensive venous ulcers (ulcers >20 cm(2) of more than 6 months' duration) with regard to healing rate, time to healing, and recurrence rate at 12 months after healing. METHODS: A total of 138 patients with extensive venous ulceration (ulceration surface, 20-210 cm(2); duration, 7 months to 28 years) were randomized into 2 groups: (1) a treatment group (72 patients who were treated by using a multilayer bandaging system with the Tubulcus (a heelless open-toed elastic compression device knitted in tubular form) and elastic bandages and (2) a control group (66 patients treated with a multilayer bandaging system with elastic bandages only). The patients were treated on an ambulatory basis; the primary end point of the study was complete ulcer healing at 500 days. The secondary end point was to assess the ulcer recurrence rate during continuation of below-knee compression of different degrees of compression. In the treatment group, patients were instructed to continue to wear the Tubulcus (35 mm Hg), and patients in the control group were instructed to wear compression stockings with compression of 20 to 25 mm Hg. The exclusion criteria from the study were heart insufficiency with an ejection fraction <35, an ankle-brachial pressure index less than 0.8, and pregnancy. RESULTS: The cumulative healing rate was 93% in the treatment group and was 51% in the control group (P < .001). The median healing time in the treatment group was 133 days (range, 28 to 464 days), and in the control group it was 211 days (range, 61 to 438 days). The recurrence rate at 12 months in the treatment group was 24% (16/67) and was 53% (18/34) in the control group (P < .05). After additional compression treatment with the same treatment protocol, all 16 recurrent ulcers in the treatment group healed. In the control group, the healing rate of recurrent ulcers was 89% (16/18). CONCLUSIONS: This study suggests that for extensive venous ulceration, multilayer compression therapy with the Tubulcus provides an extremely high healing rate. Compression of more than 30 mm Hg results in decreased ulcer recurrence. However, recurrence cannot be completely avoided.